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Purpose

The goal of this clinical trial is to learn if a culturally-adapted intervention can improve cardiovascular health in American Indian women. The main questions it aims to answer are: - Can this intervention realistically work for American Indian women? - Do American Indian women find the intervention acceptable? - Does the intervention help improve cardiovascular health in American Indian women? Researchers will compare the intervention group to a control group (a group that does not receive the intervention) to see whether the cardiovascular health of the intervention group improves. Participants will: - Attend 3 data collections over 3 months. - Be randomly assigned to either the intervention group or a control group. - (Intervention group participants) attend 8 weekly classes.

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Women 18-55 years old who self-identify as Lumbee Indian and - Have one or more risk factors for cardiovascular disease: - overweight/obese, defined as BMI >25 kg/m^2 - hypertensive as measured by study staff - physical inactivity - Willing and able to follow study procedures

Exclusion Criteria

  • Women currently enrolled in an organized weight-loss or mindfulness program - Pregnant women or women planning to become pregnant during the study period - Conditions that exclude study enrollment include: - heart murmur - congenital heart disease - family history of sudden death - or orthopedic limitations or health conditions precluding exercise

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)
Masking Description
Research assistants collecting research data

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention Group 		Intervention Group: 8-week culturally-adapted intervention
  • Behavioral: Culturally-adapted intervention to improve cardiovascular health in American Indian women
    A culturally-adapted cardiovascular health promotion intervention delivered for 8-weeks with American Indian women at risk for cardiovascular disease
No Intervention
Control Group 		Control Group: receives no intervention during the study

Recruiting Locations

UNC Health Primary and Specialty Care at Pembroke
Pembroke, North Carolina 28372
Contact:
Practice Manager
910-775-9027
Paula.Mclean@unchealth.unc.edu

More Details

Status
Recruiting
Sponsor
University of North Carolina, Chapel Hill

Study Contact

Jada Brooks
919-966-4260
jada@email.unc.edu

Detailed Description

Conduct a 3-month randomized controlled pilot study to examine feasibility, acceptability, and initial efficacy of an 8-week, culturally-adapted intervention in American Indian women at risk for cardiovascular disease on the following outcomes: Primary cardiovascular health outcomes: - blood pressure - heart rate variability - inflammatory markers - metabolic function Secondary outcomes: - stress - positive psychological well-being - health behaviors (diet, exercise) - self-regulation - self-efficacy

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.